FAIRFAX, Va.--(BUSINESS WIRE)--Vizuri Health Sciences LLC, a pharmaceutical and over-the-counter (OTC) product development company, today announced the initiation of clinical study VZU00025: A Phase 2 Clinical Trial to Examine the Comparative Effects on Osteoarthritic Knee Pain of CGS-200-1 (1% capsaicin content), CGS-200-5 (5% capsaicin content), and CGS-200-0 (placebo) (www.clinicaltrials.gov).
The ongoing multi-center, randomized, double-blind study will compare the effects of CGS-200-5 (5% capsaicin), CGS-200-1 (1% capsaicin), and CGS-200-0 (vehicle; no capsaicin) on pain in subjects who have osteoarthritis (OA) of the knee as defined by the 1986 American College of Rheumatology criteria. Study subjects will be randomized to receive four consecutive days of either CGS-200-5 (N=40), CGS-200-1 (N=40), or CGS-200-0 (N=40) treatment and will then be followed for an additional 90 days.
Pain will be assessed throughout using the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) and Visual Analogue Scale (VAS) methods. Efficacy, tolerability, and safety assessment data will be collected on Day 1 through Day 5 and then again on Days 19, 35, 64 and 94. Investigators, site staff, and contract personnel will be blinded to treatment assignments throughout the study.
William Moore, PhD, Vizuri’s Chief Executive Officer stated, “The filing of the company’s first IND and the initiation of the Phase 2 CGS-200 OA knee pain study are important milestones that underscore our commitment to develop safe, effective, and convenient non-opiate products for the treatment of chronic pain. The prescription-strength, CGS-200 capsaicin formulation complements our commercially-available OTC product, PainBloc24®. We believe that together these topical capsaicin product formulations will provide osteoarthritis sufferers a spectrum of safe and effective dose-strength options for the management of their nerve pain.”
OA is the most common form of arthritis. It most frequently occurs in the knees, hips, and hands. According to the U.S. Centers for Disease Control and Prevention, in the years 2013-2015, an estimated 54.4 million (22.7%) adults had doctor-diagnosed arthritis with higher age-adjusted prevalence in women (23.5%) than in men (18.1%). The prevalence of arthritis is expected to increase in the aging U.S. population and by the year 2040, an estimated 78.4 million (25.9%) adults will have doctor-diagnosed arthritis and two-thirds of those will be women. Also by 2040, an estimated 34.6 million adults (11.4% of all U.S. adults) will report arthritis-attributable activity limitations. Inactivity due to arthritis is associated with conditions such as cardiovascular disease, diabetes, and obesity.
Vizuri’s Patented Products for the Management of Nociceptive Nerve Pain
Affected osteoarthritic joints frequently present with multiple structural alterations to bone and synovial tissue. Synovitis and increased bone marrow lesions have been associated with increased OA pain. Synovium and bone are densely innervated by nociceptive nerve fibers, which become increasingly sensitized (e.g., elicit pain signals in response to normal movements) during the progression of OA disease.
Capsaicin, the naturally occurring substance in chili peppers that makes them taste spicy hot, exerts an initial pain-dulling sensation through its activation of heat-sensing, transient receptor potential vanilloid 1 ion channels on nociceptive sensory neurons. Prolonged stimulation of these neurons with capsaicin results in sensory neuron desensitization.
Vizuri’s first commercial product, PainBloc24® (www.painbloc24.com), contains the highest concentration of capsaicin, 0.25%, safely permitted in a topical analgesic OTC product by the U.S. Food and Drug Administration (FDA) according to its Tentative Final Monograph (TFM), “External Analgesic Drug Products for Over-the-Counter Human Use.” Vizuri has demonstrated in controlled clinical studies that once- or twice-daily topical application of PainBloc24® for four to seven days can provide a 24-hour reduction in the pain associated with OA of the knee. PainBloc24® is currently available at select drug and grocery retail stores including CVS, Rite Aid, Publix, Kroger, Giant Eagle, and Meijer among others.
The CGS-200 formulations that are being evaluated in VZU00025 contain four or twenty times greater concentrations of capsaicin than does PainBloc24®. CGS-200, like PainBloc24®, utilizes patented NeuroMax® technology, which is thought to enhance activity by allowing the tolerable topical administration of high-concentration capsaicin formulations. Vizuri believes that PainBloc24® and CGS-200 products hold significant promise as safer, non-addictive alternatives to opioids, steroids, and NSAIDs for the management of nerve pain in joints in addition to the knee, thereby positioning them more broadly as potential treatments for musculoskeletal pain. Like PainBloc24®, the CGS-200 high-strength topical capsaicin formulations can be self-administered without a need for prior treatment of the affected area with cooling or with a topical or injected analgesic.
About Vizuri Health Sciences LLC (www.vizuriusa.com)
Privately-owned Vizuri develops and markets new innovative pharmaceutical and OTC products. The products are based on proprietary formulations that use patented technologies to enhance the efficacy and safety of natural and pharmaceutical ingredients that have proven health benefits. Vizuri wholly owns the patented CGS-200 and PainBloc24® products.